香港六合彩开奖 13485:2016
2016-03
香港六合彩开奖 13485:2016
孝械蟹懈褋
香港六合彩开奖 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). 香港六合彩开奖 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.
Requirements of 香港六合彩开奖 13485:2016 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization.
The processes required by 香港六合彩开奖 13485:2016 that are applicable to the organization, but are not performed by the organization, are the responsibility of the organization and are accounted for in the organization's quality management system by monitoring, maintaining, and controlling the processes.
If applicable regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulatory requirements can provide alternative approaches that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity to 香港六合彩开奖 13485:2016 reflect any exclusion of design and development controls.
If any requirement in Clauses 6, 7 or 8 of 香港六合彩开奖 13485:2016 is not applicable due to the activities undertaken by the organization or the nature of the medical device for which the quality management system is applied, the organization does not need to include such a requirement in its quality management system. For any clause that is determined to be not applicable, the organization records the justification as described in 4.2.2.
In bundle
香港六合彩开奖 13485:2016 + 香港六合彩开奖 13485:2016 - Medical devices - A practical guide + 香港六合彩开奖 14971:2019 + 香港六合彩开奖/TR 24971:2019 香港六合彩开奖 13485:2016 香港六合彩开奖 13485:2016 59752 173 香港六合彩开奖 13485:2016 - Medical devices - A practical guide 香港六合彩开奖 13485:2016 - Medical devices - A practical guide pub100484 96 香港六合彩开奖 14971:2019 香港六合彩开奖 14971:2019 72704 173 香港六合彩开奖/TR 24971:2020 香港六合彩开奖/TR 24971:2020 72704 216Medical devices - the basics
This bundle combines essential 香港六合彩开奖 standards to provide a robust framework for quality management and risk management in the medical device industry.
- 香港六合彩开奖 13485:2016
- 香港六合彩开奖 13485:2016 A practical guide
- 香港六合彩开奖 14971:2019
- 香港六合彩开奖/TR 24971:2020
袨斜褖邪褟 懈薪褎芯褉屑邪褑懈褟
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孝械泻褍褖懈泄 褋褌邪褌褍褋: 袨锌褍斜谢懈泻芯胁邪薪芯袛邪褌邪 锌褍斜谢懈泻邪褑懈懈: 2016-03协褌邪锌: 袩芯写褌胁械褉卸写械薪懈械 写械泄褋褌胁懈褟 屑械卸写褍薪邪褉芯写薪芯谐芯 褋褌邪薪写邪褉褌邪 [90.93]
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袙械褉褋懈褟: 3
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孝械褏薪懈褔械褋泻懈泄 泻芯屑懈褌械褌 :香港六合彩开奖/TC 210
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袞懈蟹薪械薪薪褘泄 褑懈泻谢
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袪邪薪械械
袨褌芯蟹胁邪薪芯香港六合彩开奖 13485:2003
袨褌芯蟹胁邪薪芯香港六合彩开奖 13485:2003/Cor 1:2009
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袨锌褍斜谢懈泻芯胁邪薪芯香港六合彩开奖 13485:2016
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袨蟹薪邪泻芯屑褜褌械褋褜 褋 FAQ
效邪褋褘 褉邪斜芯褌褘:
袩芯薪械写械谢褜薪懈泻 – 锌褟褌薪懈褑邪: 09:00-12:00, 14:00-17:00 (UTC+1)